Burks 2012.

Methods	RCT, double‐blind Placebo‐controlled
Participants	55 participants, aged 5 to 11 years, a convincing clinical history of egg allergy (shown by the development of allergic symptoms within minutes to two hours after ingesting egg) and a serum egg‐specific IgE antibody level of more than 5 kU per litre for children 6 years of age or older, or 12 kU per litre or more for those 5 years old.
Interventions	The protocol for oral immunotherapy consisted of three phases: an initial‐day dose escalation of median 18.5 mg (range 6 mg to 50 mg) a build‐up phase of median 9 mg (range 3 mg to 50 mg) a maintenance phase during which participants ingested up to 2 g of egg white powder per day Control group: placebo
Outcomes	The primary endpoint of the study was the induction of sustained unresponsiveness after 22 months The secondary endpoints were: an oral food challenge consisting of 5 g (cumulative dose) of egg white powder at 10 months after the oral immunotherapy an oral food challenge consisting of 10 g of egg powder at 22 months after oral immunotherapy an oral food challenge at 24 months of 10 g of egg white powder, followed one hour later by feeding of a whole cooked egg for children who passed the second oral food challenge adverse effects change in skin prick test (assessed at month 10, 22 and 24) egg‐specific IgG4 antibody (assessed at month 10, 22 and 24) total IgE antibody (assessed at month 10, 22 and 24) egg‐specific IgE antibody (assessed at month 10, 22 and 24) CD63+ basophils (assessed at month 10, 22 and 24)
Vested interest	Comment: this information was not available.
Notes	Supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID) (U19AI066738 and U01AI066560) and the National Institutes of Health–National Center for Research Resources Clinical Translational Science Awards and Clinical Research Centers (RR‐024128, to Duke University Medical Center; RR‐025005, to Johns Hopkins School of Medicine; RR‐025780, to National Jewish Health; RR‐029887, to Mount Sinai School of Medicine; and RR‐029884, to the University of Arkansas for Medical Sciences).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The participants were randomly assigned by means of a centralized computer algorithm
Allocation concealment (selection bias)	Low risk	Randomization by means of a centralized computer algorithm
Blinding of participants and personnel (performance bias) All outcomes	High risk	The study was blinded only for the first 10 months: the primary endpoint was evaluated after 22 months
Blinding of outcome assessment (detection bias) All outcomes	High risk	The study was blinded only for the first 10 months: the primary endpoint was evaluated after 22 months
Incomplete outcome data (attrition bias) All outcomes	Low risk	All outcomes accounted for and balance in numbers for missing data across intervention groups
Selective reporting (reporting bias)	Low risk	All outcomes pre‐specified in the protocol (NCT00461097, ClinicalTrials.gov number) were reported